A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System

Phase 1 Completed 151 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelBasic science

Summary

This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using the proprietary on-body delivery system or a handheld syringe with hypodermic needle.

Timeline

Start: 2022-05-30
Primary completion: 2023-05-14
Completion: 2023-10-03

Outcome

Met primary endpoint

paper within the pre-specified bioequivalence margins (0.80, 1.25) for both P and H, therefore meeting the criteria for bioequivalence. PMID 40514611 ↗

Publications

Wynne C, Wang B, Deng R, Li J, Eiger D, Bene Tchaleu F, Heeson S, Restuccia E. Pharmacokinetic bioequivalence of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using a handheld syringe or an on-body delivery system. J Cancer Res Clin Oncol. 2025 Jun 14;151(6):188. doi: 10.1007/s00432-025-06228-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pertuzumab	Monoclonal antibody	600 mg	Subcutaneous
Subject	Trastuzumab	Monoclonal antibody	600 mg	Subcutaneous

Indications

No indication recorded.